Kornimate/medical-research-clean huggingface dataset:
clinical outcomes with a new monofocal iol enhanced for intermediate vision

Conditions: Presbyopia

Summary: phacoemulsification with insertion of eyhance iol to improve near and intermediate vision

insertion of new intraocular lens enhanced for intermediate vision

Eligibility criteria:
inclusion criteria: * normal ocular examination apart from cataract. exclusion criteria: * previous ocular surgery. * ocular pathology or corneal abnormalities. * endothelial cell count below 2000 cells/mm2. * corneal astigmatism greater than 1.0 diopter (d) measured with scheimpflug tomography (sirius, cso, italy).
simvastatin in uveitis

Conditions: Uveitis

Summary: the study evaluates anti-inflammatory effects and safety of simvastatin in non-infectious uveitis.

3-hydroxy-3-methyl-glutaryl coenzyme a reductase inhibitors (statins) have been shown to reduce local and systemic inflammation in animal models of various autoimmune disorders including uveitis. in this open-label, randomized study clinical efficacy and tolerability of simvastatin 40 mg/day for 8 weeks is evaluated.

Eligibility criteria:
inclusion criteria: - diagnosis of active non-infectious uveitis exclusion criteria: * serious liver or kidney disease * increased transaminase levels of \>1.5 uln * planned or active pregnancy * use of fibrates, nicotinic acid, cyclosporine a, antifungal drugs, macrolide antibiotics, verapamil, and grapefruit juice (\>1 l/day).
preventing malnutrition and restoring nutritional status in hospitalized children

Conditions: Nutrition Disorders

Summary: this cluster-randomized trial will evaluate the impact of a multifaceted intervention (including electronic medical alerts) coordinated by a nutritional support team, on adherence to recommended practices for care of starved children, among health personnel of a large university hospital. a key component of the study is to assess whether improved adherence to guidelines leads to a reduction in rates of complications.


Eligibility criteria:
inclusion criteria: * medical and surgical units in a large teaching hospital providing pediatric acute care. * any hospital staff with direct patient care who are affiliated with a single unit (includes physicians, nurses, nursing assistants, physiotherapists, dieticians. * all children recorded as malnourished at their entrance in hospital exclusion criteria: * neonatal and intensive care units. * any hospital staff with direct patient care who are not affiliated with a single unit. * age under one month, liver or kidney abnormalities, severe heart failure, stay less than 2 days.

Keywords: non mesh terms: children malnutrition computer clinical decision support system cluster randomized trial healthcare workers guideline adherence patient safety mesh terms: nutrition surveys secondary prevention pediatrics child care health personnel reminder systems intervention studies quality of health care
ace2016 in adult subjects with locally advanced or metastatic solid tumors expressing epidermal growth factor receptor (egfr)

Conditions: Locally Advanced Solid Tumor; Metastatic Solid Tumor

Summary: ace2016 is an off-the-shelf, allogeneic gamma delta t (gdt) cell therapy derived from healthy donors, that is under investigation for the treatment of locally advanced or metastatic solid tumors expressing epidermal growth factor receptor (egfr). the ace2016-001 study is an open-label, phase i, first-in-human (fih) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ace2016 in patients with locally advanced or metastatic solid tumors expressing epidermal growth factor receptor (egfr).


Eligibility criteria:
inclusion criteria: * locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy) * at least one measurable lesion as defined by recist v1.1 criteria * eastern cooperative oncology group (ecog) performance status 0-1 * adequate hematologic and renal, hepatic and cardiac function * oxygen saturation via pulse oximeter ≥92% at rest on room air exclusion criteria: * prior treatment with a genetically modified cell therapy product targeting egfr * history of allogeneic transplantation * subjects with active cns metastases * history or presence of clinically relevant central nervous system (cns) disorder (e.g. epilepsy) * clinically significant active infection * human immunodeficiency virus (hiv) infection, active hepatitis b infection, or hepatitis c infection. * history of malignancies with the exception of certain treated malignancies with no evidence of disease. * primary immunodeficiency disorder * pregnant or lactating female * any medical, psychological, familial, or sociological conditions that, in the opinion of the investigator or sponsor medical monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent
the $ensible weight program: an intervention tailored for low income women

Conditions: Weight Loss

Summary: the purpose of this study is to learn if a weight loss program especially designed to address food insecurity is more effective compared to a standard weight loss program.

low income women are at greater risk of both obesity and food insecurity (not having consistent access to nutritious and adequate amounts of food). most weight loss programs targeted at low income women do not focus on gaining skills and knowledge to reduce food insecurity. eligible participants will be randomized into one of two groups. the two groups will follow different weight management programs. one group will follow a standard weight management program. the other group with follow the investigations program, the $ensible weigh program. participation in the study will last about 9 months.

Eligibility criteria:
inclusion criteria: * documented low income * body mass index (bmi) \>25.0 kg/m2 * must speak and understand english * able to attend intervention sessions and have access to telephone exclusion criteria: * report serious medical risk such as insulin-dependent diabetes, cancer, recent cardiac event * currently or planning to become pregnant during the intervention * have no control over food purchases or choices * report participation in a weight reduction program involving diet or pa within past 6 months * report symptomology of an eating disorder * report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, atkins, macrobiotic, etc.
efficacy and safety of low-dose rituximab in the treatment of refractory myasthenia gravis

Conditions: Refractory Myasthenia Gravis; Rituximab

Summary: this study is designed to evaluate the effectiveness and safety of low-dose rituximab in patients with refractory myasthenia gravis. the traditional treatment of mg is immunosuppressive therapy, usually beginning with corticosteroids. however, up to 70% of treated patients show an incomplete response, including 10 - 30% who are unresponsive. corticosteroids and other immunosuppressive therapies presented also many side effects. the investigators propose to evaluate in a pilot, open, prospective, single central study, the interest of rituximab (rtx) in the treatment of patients with refractory mg. fifty patients with refractory mg will be included in the study and divided into two stages: 14 patients in the first stage were followed up after using rtx according to the study protocol. the study will move into the second stage on if the number of effective cases is greater than 3, otherwise, the study will be discontinued (based on simon's optimal two-stage design). the remaining 36 patients were enrolled in the second stage. in the first and second stages, the treatment plan and follow-up plan were consistent. the therapeutical schema is rituximab 100-200 mg/week for a total of 2-4 times, followed by adequate organ function, laboratory parameters and assessment of mg after each injection and end of follow up for 24 weeks.


Eligibility criteria:
inclusion criteria: 1. aged 80 and under; 2. myasthenia gravis: 1. patients who are diagnosed as generalized or ocular myasthenia gravis 2. patients must have disease refractory to treatment: the condition did not improve (qmg score decreased by less than 3 points after treatment) or even deteriorated after treatment with sufficient prednisone or other immunosuppressive agents. 3. patients sign informed consent forms exclusion criteria: 1. over the age of 80 2. patients with serious complications such as infection 3. patients with active tb (during the screening period, a chest x-ray or chest ct would be performed unless the patient can provide chest x-ray or chest ct reports in the last month); or patients with active hbv, hbv dna\> 200 4. patients suffering from cardiomyopathy, acute coronary events, or severe arrhythmia. 5. patients who were allergic to rituximab 6. pregnant or suckling period woman 7. patients accompanied with mental disorders and have difficult to communication 8. patients with a significant abnormality in white blood cells, hemoglobin, and platelet count.
a study of ly3484356 in women with breast cancer before having surgery

Conditions: Breast Cancer

Summary: the purpose for this study is to see if the study drug, ly3484356, is safe and to determine what effects it has on breast cancer in participants with estrogen receptor positive (er+), her2 negative (her2-) early stage (stage i-iii) breast cancer, when given prior to surgery. participation in this study could last up to 2.5 months.


Eligibility criteria:
inclusion criteria: * have histologically confirmed invasive er+, her2- breast carcinoma * be willing and able to provide pre- and on-treatment tumor samples * have a performance status of 0 or 1 on the eastern cooperative oncology group scale * have adequate organ function * be able to swallow capsules * be a postmenopausal woman exclusion criteria: * have bilateral invasive breast cancer * have metastatic breast cancer * plan to receive concurrent neoadjuvant therapy with any other non-protocol anti-cancer therapy * have had prior therapy (of any kind) for an invasive or non-invasive breast cancer * have had prior radiotherapy to the ipsilateral chest wall for any malignancy * have had prior anti-estrogen therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (serm), either for osteoporosis or prevention of breast cancer * have had prior hormone-replacement therapy within 4 weeks of the start of study treatment * have had major surgery within 28 days prior to randomization to allow for post-operative healing of the surgical wound and site(s) * have certain infections such as hepatitis or tuberculosis or hiv that are not well controlled * have another serious medical condition * have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years

Keywords: serd
effect of the posterior ligamentous complex on the adjacent segments degeneration after lumbar surgery

Conditions: Lumbar Spinal Stenosis

Summary: to investigate whether destroying the adjacent posterior ligamentous complex (plc) has an effect on adjacent segment degeneration (asd) after l5/s1 posterior lumbar interbody fusion (plif)

purpose: to investigate whether destroying the adjacent posterior ligamentous complex (plc) has an effect on adjacent segment degeneration (asd) after l5/s1 posterior lumbar interbody fusion (plif). methods: this retrospective study was performed in patients who received l5/s1 plif with pedicle screw instrumentation for lumbar spinal stenosis with or without isthmic spondylolisthesis. they were divided into the total laminectomy group, which had destruction of the plc of the adjacent segment, or partial laminectomy group, which did not. vertebral slip, osteophytes, disk height, and range of motion were examined by plain radiography, and thickness of the ligamentum flavum (lf) and anteroposterior diameters of the lumbar vertebral body and spinal canal were assessed by magnetic resonance imaging (mri). disc degeneration and spinal stenosis on mri scans were categorized. the incidence of asd and clinical outcome were compared between the groups.

Eligibility criteria:
inclusion criteria: * typical clinical symptoms such as disabling low back or leg pain with or without neurological symptoms, intermittent claudication, with refractory to ≥6 months of strict conservative treatment; and l5/s1 single-level plif with pedicle screw instrumentation. exclusion criteria: * previous spine surgery, acute spinal fracture, infection, and tumor.

Keywords: adjacent segment degeneration lumbar posterior ligamentous complex posterior lumbar interbody fusion
effects of low-level red light and distant-image screen for myopia control in children

Conditions: Myopia

Summary: this study aims to assess the efficacy and safety of daily exposure to 650-nm low-level red light (rl) and distant-image therapy (dit) for myopia treatment.

this was a randomized clinical trial. children aged 8 to 10 years with a spherical equivalent error (ser) ranging from -1 to -1.5 diopters (d) were enrolled, and were randomly allocated to the following treatment group: rl, dit, rl plus dit, and control in a 1:1:1:1 ratio. the primary outcomes were one-year change in ser and axial length.

Eligibility criteria:
inclusion criteria: * 1. age between 8 and 10 years old. 2. the spherical equivalent error after pupil dilation was between -1.0 d and -1.5d. 3. corneal astigmatism ≤ 1.25d. 4. interocular refraction discrepancy ≤ 1.5d. 5. near-distance exophoria \< 10 prism diopters (△) and far-distance exophoria \< 6 prism diopters (△). 6. willingness to participate in the study and signed informed consent. exclusion criteria: * 1. intraocular pressure was below 10 mmhg or higher than 22 mm hg. 2. presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders. 3. children currently using atropine or orthokeratology for myopia control. 4. patients with systemic and immune disorders such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes, etc. 5. individuals with conditions like tourette's syndrome or epilepsy.

Keywords: myopia red-light distant-image screen
efficacy and safety of cyclobenzaprine hydrochloride extended release for the treatment of chronic migraine

Conditions: Chronic Migraine

Summary: the primary objective of the study is to evaluate the effectiveness and safety of cyclobenzaprine hydrochloride extended release (amrix 15mg/day) for the prophylaxis of chronic migraine compared to a placebo medication. a second objective, is to find out whether there is an improvement in quality of sleep and self-reported depression in patients taking amrix 15mg daily. the hypothesis is that the number of migraine days per month of patients treated with amrix 15mg daily will be significantly lower than those patients treated with placebo.


Eligibility criteria:
inclusion criteria: 1. males and females, aged 18 to 65, with headaches longer than 30 minutes per day for at least 15 days per month (28 days) meeting ichd-iir criteria for chronic migraine. subjects must have headaches at least 8 days per month which are alleviated with triptans or ergots and/or which have at least 1 migrainous feature (unilaterality of headache or pain more prominent on 1 side of the head, throbbing, nausea, vomiting, photophobia, phonophobia, increased pain with physical exertion or avoidance of exertion) 2. subjects willing and able to perform all study-related measures including accurately completing study diaries and instruments, maintaining stable doses of headache preventative medications, completing study visits and obtaining blood testing as indicated. 3. women of childbearing potential must use an acceptable method of birth control for the duration of the study (oral contraceptives, iud, injectable or intravaginal contraception or barrier methods combined with spermicide) exclusion criteria: 1. subjects \ 65 years of age 2. pregnancy or attempted pregnancy during the study 3. nursing females 4. psychiatric condition which, in the investigator's opinion will influence trial safety or data collection 5. new daily persistent headache, hemicrania continua, chronic tension-type headache or cluster headache diagnoses. 6. headache suspicious for and not investigated to rule out secondary headache disorder 7. angle closure glaucoma 8. urinary retention 9. hepatic impairment felt by the investigator to interfere with study safety (as determined from history and/or prerequisite liver function testing within 1 year of study enrollment) 10. within 14 days of mao inhibitor use or discontinuation 11. known hypersensitivity to cyclobenzaprine hydrochloride or any component of amrix formulation 12. concomitant tramadol or tricyclic antidepressant use 13. history of myocardial infarction or congestive heart failure 14. hyperthyroidism 15. new start of daily preventative medication (which may influence headaches) less than 2 months preceding enrollment 16. dosage change or discontinuation of daily preventative medication (which may influence headaches) within 1 month of trial enrollment -

Keywords: migraine
perceval s valve clinical study for chinese registration

Conditions: Aortic Valve Disease; Aortic Valve Stenosis

Summary: this is a prospective, open, single arm, multi-center clinical study in china. the primary objective of this study is to demonstrate the safety and effectiveness of the perceval s heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated chinese population for tissue heart valve replacement and suitable to the perceval s valve. the secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.


Eligibility criteria:
inclusion criteria: 1. subject of age \> 60 years. 2. subject with aortic valve stenosis or steno-insufficiency. 3. subject has signed the informed consent. 4. subject in which preoperative evaluation is indicated for the need of native or prosthetic aortic valve replacement via open heart surgery 5. subject is located in a geographic location that will enable the subject to return to the study site for follow-up examinations (i.e. geographically stable). exclusion criteria: 1. subject has preexisting valve prosthesis or annuloplasty rings in the mitral, pulmonic or tricuspid position. 2. subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve. 3. subject requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass graft (cabg). 4. subject has active endocarditis. 5. subject has active myocarditis 6. subject has aneurysmal dilation or dissection of the ascending aortic wall. 7. subject is drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent. 8. subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject. 9. subject with known hypersensitivity to nickel alloys. 10. subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism. 11. subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized for ≥30 days prior to the planned valve implant surgery. 12. subject is known to be noncompliant or is unlikely to complete the study. 13. subject with an aortic root enlargement, where the ratio between the diameter of the stj and the annulus diameter, assessed by tee, is \> 1.3. or for other anatomical reasons that not suitable for perceval s per ib.
nutrition-focused quality improvement program (qip) among community dwelling malnourished patients

Conditions: Malnutrition

Summary: this study aims to assess the malnutrition prevalence of colombian community-dwelling adults and evaluate the feasibility of a nutrition-focused qip implemented in a colombian ambulatory care facility on healthcare utilization.


Eligibility criteria:
inclusion criteria: * patient is screened as being malnourished or at risk for malnutrition * patient can consumer beverages and food orally * patients have a life expectancy of equal or greater than 90 days * patient is literate and willing to voluntarily sign and date an informed consent form (icf) after it is explained exclusion criteria: * patient is pregnant * patient is intubated, receiving tube feeding or parenteral nutrition * patient has severe dementia, delirium or history of significant psychiatric disorder and no dedicated caregiver who could assure their compliance with qip study requirements and help with the completion of qip study materials * any other disorder that may interfere with qip product consumption or compliance with qip protocol procedures * patient has an allergy or intolerance to any of the ons ingredients * patients does not want to participate or sign icf * patient is bedridden or confined in a wheelchair
an observational study of distress, immune function, and pain in hiv.

Conditions: Chronic Pain; HIV; Distress, Emotional; Immune System and Related Disorders; Central Sensitisation

Summary: this case-control study focuses on pain in hiv, which is common despite antiretroviral therapy and compromises quality of life, mental health and daily functioning. specifically, it will investigate the relationships between psychosocial distress, inflammation and pain in hiv.

we plan to recruit 100 people and follow them for 6 months, taking repeated measures. participants who report persistent pain at enrolment will be assessed at 0 (baseline), 2, 4, and 6 months. participants who report no pain at enrolment will be assessed at 0 (baseline) and 6 months. all participants will also be invited to participate in weekly remote assessment of selected self-reported outcomes.

Eligibility criteria:
inclusion criteria: * hiv-positive with viral suppression * report either persistent pain or no pain at enrolment exclusion criteria: * pregnancy * acute psychiatric condition requiring urgent care * cognitive impairment preventing full participation

Keywords: chronic pain hiv innate immune response mental health hyperalgesia, secondary
short vs long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization

Conditions: Peripheral Arterial Disease; Endovascular Procedures

Summary: the primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.


Eligibility criteria:
inclusion criteria: 1. provide signed informed consent before initiation of any study related procedures 2. be at least 18 years of age 3. successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent). 4. at least 1 vessel run-off in segment distal to the intervention 5. rutherford classification 2-5 that is unresponsive to medical therapy exclusion criteria: 1. acute limb ischemia 2. procedure includes device deployment that has specific fda regulations for anticoagulation/anti-platelet medication regimen. 3. patient undergoing atherectomy procedure 4. intervention includes deployment of drug eluted stent 5. critical limb ischemia (rutherford classification 6) 6. thrombocytopenia: platelet count \<50k 7. liver disease (childs-pugh b or c) 8. existing need for on going clopidogrel therapy 9. proton pump inhibitor use (if unable to be switched) 10. need for therapeutic anticoagulation 11. known hypercoagulable disorder 12. allergy or contraindication to aspirin or clopidogrel 13. pregnancy 14. patients enrolled in another investigational drug or device study within the past 30 days